IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Prospective Observational Epidemiologic Study of Maraviroc's Safety (POEM)
This study is ongoing, but not recruiting participants.
Sponsor:
ViiV Healthcare
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00665561
First received: April 23, 2008
Last updated: August 16, 2017
Last verified: August 2017
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.
| Condition | Intervention |
|---|---|
| Human Immunodeficiency Virus | Drug: Maraviroc along with an optimized background antiretroviral drug regimen Drug: Optimized background antiretroviral drug regimen without maraviroc |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | An International, Multicenter, Prospective Observational Study Of The Safety Of Maraviroc Used With Optimized Background Therapy In Treatment-experienced Hiv-1 Infected Patients |
Resource links provided by NLM:
Further study details as provided by ViiV Healthcare:
Primary Outcome Measures:
- CDC Category C AIDS defining infections, Viral encephalitis, Rhabdomyolysis, Liver failure, Liver related deaths [ Time Frame: Followed till 6 months after drug discontinuation up to a total of 5 years. ]
- All Malignancies (AIDS defining and non-AIDS defining), Myocardial ischemia or infarction, All cause mortality [ Time Frame: Followed for a total of up to 5 years regardless of the time of drug discontinuaion. ]
Secondary Outcome Measures:
- There are no Secondary Outcomes for this study. [ Time Frame: 0 ]
| Enrollment: | 2454 |
| Actual Study Start Date: | March 31, 2008 |
| Estimated Study Completion Date: | February 26, 2019 |
| Estimated Primary Completion Date: | February 26, 2019 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Maraviroc exposed |
Drug: Maraviroc along with an optimized background antiretroviral drug regimen
Maraviroc prescribed per approved local label.
Other Name: Selzentry
|
| Maraviroc unexposed |
Drug: Optimized background antiretroviral drug regimen without maraviroc
Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.
|
Detailed Description:
All patients meeting the study eligibility criteria at participating sites will be invited to participate.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Treatment experienced, HIV-1 infected patients in routine clinical practice.
Criteria
Inclusion Criteria:
- Treatment experienced, HIV-1 infected patients
- 18 years or older
- Receive an approved assay for determination of HIV-1 tropism
Exclusion Criteria:
- Pregnant or lactating
- Using CCR5 inhibitor other than maraviroc
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665561
Show 266 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665561
Show 266 Study Locations
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT00665561 History of Changes |
| Other Study ID Numbers: |
A4001067 2007-006148-24 ( EudraCT Number ) POEM ( Other Identifier: Alias Study Number ) |
| Study First Received: | April 23, 2008 |
| Last Updated: | August 16, 2017 |
Keywords provided by ViiV Healthcare:
|
Maraviroc HIV-1 Safety Non-interventional |
Additional relevant MeSH terms:
|
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Slow Virus Diseases Maraviroc CCR5 Receptor Antagonists Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on August 21, 2017